An Open-label Study to Evaluate the Pharmacokinetics of Oral Tenapanor in Breast Milk of Lactating Females

NCT06203444 | Completed Phase 1 FDA Drug

• 1 other identifier: TEN-01-109
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

Brief Summary

This is an open label study to investigate PK of tenapanor and AZ13792925 in breast milk of lactating female subjects.

Conditions

Lactation

Outcome Measures

Primary Outcomes (1)

• Concentration of tenapanor and its major metabolite in breast milk

  The primary objective of the study is to determine the maximum observed milk concentration (Cmax) of tenapanor and its primary metabolite AZ13792925 in the breast milk of lactating female subjects.

  26 Days

Secondary Outcomes (1)

• The safety of tenapanor in lactating females

  26 Days

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Eligible subjects will be enrolled to receive the study drug

Drug: Tenapanor

Interventions

Tenapanor DRUG

The study drug will be administered in dose of 50 mg bid

Also known as: IBSRELA

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Lactating Females
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must satisfy all of the following criteria at the Screening visit unless otherwise stated:
• Females greater than or equal to 18 years of age.
• Body mass index between 18.0 and 35.0 kg/m2, inclusive.
• In good health with no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory as determined by the Investigator.
• Females must be non-pregnant.
• Has been breastfeeding or actively pumping for at least 4 weeks.
• Willing to continue regular pumping in order to maintain milk supply for the duration of the study.
• Will not feed infant breast milk while taking tenapanor and for 72 hours post the last dose of tenapanor.
• Weaning must not be underway, to ensure an adequate milk supply.
• Able to comprehend and willing to sign an ICF and to abide by the study restrictions

You may not qualify if:

• Subjects will be excluded from the study if they satisfy any of the following criteria at the Screening visit unless otherwise stated:
• Significant medical or psychiatric disorder, as determined by the Investigator that would interfere with participation.
• Use or intend to use any prescription or non-prescription medications 4 days before first dose of tenapanor until Day 6 of the study, unless deemed acceptable by the Investigator and/or Sponsor.
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
• Has mastitis or other condition that would prevent the collection of milk from one or both breasts.
• Loose stools (Type 6 or 7 on the Bristol Stool Form Scale) ≥2 days in the past 7 days
• Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days prior to dosing or 5 half-lives prior to dosing.
• Subjects who, in the opinion of the Investigator (or designee), should not participate in this study

Sponsors & Collaborators

• Ardelyx: lead

Study Sites (2)

DDSI

Oklahoma City, Oklahoma, 73112, United States

Location

Fortrea Clinical Research Unit

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

tenapanor

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Susan Edelstein, PhD

  Ardelyx

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An open-label study to investigate the PK of tenapanor and AZ13792925 in breast milk of lactating female subjects

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 12, 2024
• Study Start: November 27, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)